Hansa Biopharma (HNSA) Redburn Gene Therapy Summit presentation summary

Corporate overview and financials

• Validated technology with EU approval for kidney transplantation in HLA-sensitized patients and clinical proof of concept in autoimmune disease.

• Multiple ongoing clinical studies in the US and EU, including pivotal trials for Idefirix and studies in anti-GBM disease and Guillain-Barré syndrome.

• Organization has grown rapidly to 113 employees, with significant life science experience and headquarters in Lund, Sweden.

• Cash position of $130M as of June, providing funding into 2023 to support EU launch and technology expansion.

• Listed on NASDAQ Stockholm with a market cap of ~$0.7bn and 17,000 shareholders, half of whom are foreign investors.

Lead product and technology

• Imlifidase is a unique IgG antibody-cleaving enzyme, enabling fast and effective IgG elimination in patients.

• Approved in the EU for enabling kidney transplantation in highly sensitized patients; US pivotal study ongoing.

• Demonstrated potential to eliminate neutralizing antibodies (Nabs), facilitating gene therapy by pre-treatment.

• Recent publications confirm imlifidase's ability to cleave anti-AAV antibodies, increasing transgene expression in Nab+ environments.

Pipeline and partnerships

• Pipeline includes indications in transplantation, autoimmune diseases, and gene therapy, with several programs in preclinical to phase 3 stages.

• Collaboration with Sarepta Therapeutics for Duchenne and Limb-Girdle Muscular Dystrophy, with Hansa providing imlifidase know-how and Sarepta leading development and commercialization.

• Hansa eligible for up to $397.5M in milestone payments and royalties from Sarepta, plus upfront payment of $10M.

• Preclinical programs target large gene therapy indications, with 30% of GTx patients Nab+ pre-first dose.